Qvar

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Qvar

SIDE EFFECTS

The following reporting rates of common adverse experiences
are based upon 4 clinical trials in which 1196 Patients (671 female and 525
male adults previously treated with as-needed bronchodilators and/or inhaled
corticosteroids) were treated with QVAR (doses of 40, 80, 160, or 320 mcg twice
daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. The
table below includes all events reported by patients taking QVAR (whether
considered drug related or not) that occurred at a rate over 3% for either QVAR
or CFC-BDP. In considering these data, difference in average duration of
exposure and clinical trial design should be taken into account.

Adverse Events Reported by at Least 3% of the Patients
for Either QVAR or CFC-BDP by Treatment and Daily Dose

Adverse Events

QVAR

CFC-BDP

Placeb
(N=289) %

Total
(N=624) %

80-160 mcg
(N=233) %

320 mcg
(N=335) %

640 mcg
(N=56) %

Total
(N=283) %

84 mcg
(N=59) %

336 mcg
(N=55) %

672 mcg
(N=169) %

HEADACHE

9

12

15

8

25

15

14

11

17

PHARYNGITI S

4

8

6

5

27

10

12

9

10

UPPER RESP TRACT INFECTION

11

9

7

11

5

12

3

9

17

RHINITIS

9

6

8

3

7

11

15

9

10

INCREASED ASTHMA SYMPTOMS

18

3

2

4

0

8

14

5

7

ORAL SYMPTOMS INHALATION ROUTE

2

3

3

3

2

6

7

5

5

SINUSITIS

2

3

3

3

0

4

7

2

4

PAIN

< 1

2

1

2

5

3

3

5

2

BACK PAIN

1

1

2

< 1

4

4

2

4

4

NAUSEA

0

1

< 1

1

2

3

5

5

1

DYSPHONIA

2

< 1

1

0

4

4

0

0

6

Other adverse events that occurred
in these clinical trials using QVAR with an incidence of 1% to 3% and which
occurred at a greater incidence than placebo were: dysphonia, dysmenorrhea and
coughing.

No patients treated with QVAR in
the clinical development program developed symptomatic oropharyngeal
candidiasis. If such an infection develops, treatment with appropriate
antifungal therapy or discontinuance of treatment with QVAR may be required.

Pediatric Studies

In two 12-week placebo-controlled
studies in steroid naive pediatric patients 5 to 12 years of age, no clinically
relevant differences were found in the pattern, severity, or frequency of
adverse events compared with those reported in adults, with the exception of
conditions which are more prevalent in a pediatric population generally.

Adverse Event Reports from Other
Sources

Rare cases of immediate and
delayed hypersensitivity reactions, including urticaria, angioedema, rash, and
bronchospasm, have been reported following the oral and intranasal inhalation
of beclomethasone dipropionate.

During postmarketing experience,
psychiatric events and behavioral changes such as aggression, depression, sleep
disorders, psychomotor hyperactivity, and suicidal ideation have been reported
(primarily in children). Because these events are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.